Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA

In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application (NDA) for ALKS 5461, a treatment for major depressive disorder, the company announced this morning. The FDA rejected the NDA at the end of March over a lack of data.

Alkermes said it did not submit any additional data to the FDA as was initially suggested by the regulatory agency. During a brief conference call this morning Alkermes Chief Executive Officer Richard Pops said the company submitted "an enormous amount of information" to the FDA for the NDA. After the initial rejection of the NDA the company held a number of talks with regulatory officials and Pops said it took a while "to get the lens focused the right way" for the FDA to accept the NDA. The FDA's target action date for the ALKS-5461 NDA is Jan. 31, 2019.

Following the company’s announcement this morning shares of Alkermes shot up more than 14 percent in premarket trading to hit $48.79. The company still has not regained the value it lost after the FDA initially sent a Refusal to File letter to the company at the end of March when it was trading at $57.96 per share.

Craig Hopkinson, Chief Medical Officer at Alkermes, said that the FDA’s filing of ALKS-5461 is a "positive step forward" for patients suffering from major depressive disorder. He said the company will continue to work with the FDA throughout the review process as Alkermes hopes to bring the medicine to market.

The FDA initially refused the NDA for ALKS-5461 due to a lack of "insufficient evidence of overall effectiveness for the proposed indication." In its Refusal to File letter the FDA said Alkermes would likely have to initiate additional clinical trials in order to support a resubmission. Additionally, the FDA requested for the company to conduct a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.  

In the two weeks since that initial Refusal to File letter was issued Pops said the company has engaged with the FDA in a series of meetings to seek acceptance of the NDA. It was during those meetings that Pops said the company clarified the data it had submitted.

ALKS-5461 is a proprietary, investigational, once-daily oral medicine that acts as a balanced neuromodulator in the brain and represents a novel mechanism of action for treating MDD. ALKS 5461 consists of samidorphan and buprenorphine, and is designed to rebalance brain function that is dysregulated in the state of depression. Alkermes filed its NDA at the end of January based on positive data from its Phase III FORWARD-5 trial. That study, completed in late 2016, showed a 2 milligram dose of ALKS 5461 reduced depression scores compared to placebo as measured by 6-item Montgomery–Åsberg Depression Rating Scale. It was a big turnaround for the drug after Alkermes reported that two of its three clinical trials studying ALKS 5461 in depression failed to meet their primary endpoints.

Over the past year, the FDA has reversed a number of rejections for both the filing and approval of new medications. In 2917 the FDA did an about-face on Amicus’ Fabry disease treatment, as well as Eli Lilly’s rheumatoid arthritis drug baricitinib and TherapeuticsMD, Inc.’s vaginal pain medicine TX-004HR.

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